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Cedars-Sinai Senior IRB Analyst, Team Lead - Research Compliance & Quality Improvement in Los Angeles, California

Our Senior IRB Analyst, Team Lead is a professional position working under the general supervision of Manager, IRB Operations. The incumbent will provide high-level professional support to assist the Manager in the day-to-day operations of the IRB.

Job responsibilities include:

  • Together with the Manager of IRB Operations, manage workload and distribute IRB submissions for processing among the team of IRB analysts and help ensure the high-quality review of IRB submissions in accordance with established timelines.

  • Assist the Manager of IRB Operations with staff onboarding, training and mentoring, and participate in decisions related to hiring, engagement and management of IRB analysts.

  • Provide consultation and serve as a resource for IRB analysts for all questions/issues related to IRB operations.

  • Plan and help lead regular IRB analyst team meetings, including creation/distribution of agendas and assignment of follow-up tasks resulting from meeting discussions.

  • Working with the Quality Improvement and Education team, provide input into the development and revision of policies, procedures, work instructions, educational materials and tools to support IRB operations.

  • Provide consultation and support to the research community, ancillary departments and IRB members on all matters related to the submission and review of IRB applications.

  • Process the review and approval of IRB submissions to stay on top of current procedures and for coverage as needed.

  • Together with the Manager of IRB Operations, provide support for IRB meeting management, including preparation of meeting agendas and minutes, and provide regulatory expertise to guide IRB chairs and members during the meetings.

  • Together with the Manager, provide domain expertise and feedback on the IRB on-line system with respect to IRB operations processes. Specific areas of focus include: the IRB application form, IRB meeting management, and workflow/functionality related to the IRB submission, review and approval process.

  • Assist the Manager and Executive Director in maintaining full AAHRPP accreditation for the institutional human research protection program. Help draft AAHRPP accreditation renewal applications, training materials for site visits, and responses to site visits.

  • Conduct special projects as assigned by the Manager, IRB Operations or the Executive Director of Research Compliance and Quality Improvement.

Education:

  • High School required

  • Bachelor’s degree preferred

Qualifications and experience:

  • Five (5) years experiences in IRB administration, research compliance, biomedical research, or the equivalent.

  • Direct experience in IRB administration is preferred.

  • “Certified IRB Professional” or equivalent is required within 6 months of hire.

  • Detailed knowledge of federal, State, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research and working knowledge of scientific and medical concepts and terminology.

  • Excellent written and verbal communication and interpersonal skills.

  • Ability to effectively collaborate with multiple departments and a strong team work ethic.

  • Ability to work independently with self-motivation and initiative, while also knowing when to refer issues to Manager or Executive Director.

  • Strong problem-solving, organizational and analytical skills, resourcefulness and research skills, attention to detail and ability to work under pressure to meet deadlines.

  • Ability to perform multiple tasks with a high level of accuracy and attention to details.

  • Ability to meet production within established time and quality standards.

  • Computer proficient - must have strong Excel, Word, presentation, and database skills.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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